The Effect of Regional Anaesthesia and Genetic Factors in the Development of Chronic Pain Following Total Knee Arthroplasty
1 other identifier
interventional
200
1 country
1
Brief Summary
The study aims to assess the effect of spinal anaesthesia against a general anaesthesia with a femoral block, with respect to the incidence of chronic pain following a total knee replacement. It will also focus on genetic factors and their influence on chronic pain.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2017
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2017
CompletedFirst Submitted
Initial submission to the registry
December 12, 2019
CompletedFirst Posted
Study publicly available on registry
December 20, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2023
CompletedOctober 26, 2022
October 1, 2022
5 years
December 12, 2019
October 25, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Pain Numerical Rating Scale on physiotherapy
Pain Numerical Rating Scale, from 0 (no pain) to 10 (severe pain)
24 hours
WOMAC Score at 3 and at 6 months
WOMAC score, ranging from 0 to 94
6 months
WOMAC Pain Score at 3 and at 6 months
WOMAC Pain score, ranging from 0 (no pain) to 20 (severe pain on numerous activities)
6 months
Secondary Outcomes (5)
Morphine consumption
24 hours
Pain Numerical Rating Scale after 6 months
6 months
Incidence of Chronic Post-surgical Pain
6 months
Change in WOMAC Score at 3 and at 6 months
6 months
Change in WOMAC Pain Score at 3 and at 6 months
6 months
Study Arms (2)
General Anaesthesia
ACTIVE COMPARATORPatients will receive a general anaesthetic, together with a femoral nerve block.
Spinal Anaesthesia
ACTIVE COMPARATORPatients will receive a spinal anaesthetic
Interventions
patients will receive a general anaesthetic and a femoral nerve block
Eligibility Criteria
You may qualify if:
- patients able to undergo a total knee arthroplasty
You may not qualify if:
- age more than 75 years
- known case of chronic pain syndromes
- arthroplasty not due to osteoarthritis
- sensitivity to any drugs used in protocol
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mater Dei Hospital
Msida, MSD2090, Malta
Related Publications (1)
Sciberras SC, Vella AP, Vella B, Spiteri J, Mizzi C, Borg-Xuereb K, LaFerla G, Grech G, Sammut F. A randomized, controlled trial on the effect of anesthesia on chronic pain after total knee arthroplasty. Pain Manag. 2022 Sep;12(6):711-723. doi: 10.2217/pmt-2021-0081. Epub 2022 Mar 30.
PMID: 35350864DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDIV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lead investigator
Study Record Dates
First Submitted
December 12, 2019
First Posted
December 20, 2019
Study Start
June 1, 2017
Primary Completion
June 1, 2022
Study Completion
December 30, 2023
Last Updated
October 26, 2022
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will not share